You manufacture medical devices. These products must be furnished with certificates in order to be allowed on the market in various countries. As Notified Body, KEMA can combine both the product testing and the system certification in a single audit.  

In some cases, you might be dealing with different directives depending on your medical device. Your product will only be allowed on the market if it complies with these directives. So it’s good to know that KEMA is accredited for all these directives. 

One-stop shopping: KEMA!

Now you can have all your testing and certifying taken care of at one institute:  KEMA. 
KEMA knows the medical world better than anyone else. Our auditors are experts. They combine their knowledge with a vast amount of experience in the medical industry.  

KEMA has been designated as Notified Body for the following directives:

• 90/385/EEG Active Implantable Medical Devices
• 93/42/EEG Medical Devices 
• 98/79/EEG In Vitro Diagnostics 
• 2003/32/EC Medical devices manufactured utilizing tissues of animal origin 
• 89/336/EEC EMC Directive
• 99/5/EC Radio and Telecommunications Terminal Equipment 
• IEC 601             

KEMA has been accredited by Health Canada for: 

• CMDCAS 
• 13485: 2003            

KEMA is the partner of the FDA for:

• 510(k)            

We are totally thorough, completely independent, and extremely flexible.  At the same time, we take your situation fully into consideration. KEMA understands that as a manufacturer your interests are best served when your time to market is as short as possible.  KEMA has a reputation for being fast, professional, and reliable. This assures you of the shortest possible time to market – and that saves you time and money. 

For more information please contact us.